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Effect of Gasro-Fix on children acute diarrhea

A clinical trial to compare the effectiveness of Gasro-Fix and placebo (lactose free dried milk) on duration of diarrhea among children with acute gastroenteritis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017091536195N1
Enrollment
150
Registered
2017-10-12
Start date
2017-11-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: gastroenteritis. Condition 2: gastroenteritis. Viral intestinal infection, unspecified Other viral enteritis

Interventions

Intervention 1: Intervention group: patients will receive Gasro-Fix, 9 g/kg in two to four divided doses per day. Intervention 2: Control group: patients will receive lactose-free formula 9 g/kg in tw
Treatment - Other
Intervention group: patients will receive Gasro-Fix, 9 g/kg in two to four divided doses per day.
Control group: patients will receive lactose-free formula 9 g/kg in two to four divided doses per day

Sponsors

Vice Chancellor for research of Alborz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 5 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: child patients aged 6-60 months; diarrhea defined as the passage of three or more loose or liquid stools in 24 hours; diarrhea lasting at least 24 hours; and not exceeding two weeks from presentation of the disease; diarrhea with or without fever, vomiting, mucus in stool; Body weight more than 8 kg. Exclusion criteria: acute diarrhea that contains blood; chronic diarrhea; severe dehydration; inflammatory bowel disease; necrotizing enterocolitis; immune deficiency; chronic disease and malnutrition.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Length of hospitalization. Timepoint: after intervention. Method of measurement: Number of hospitalization days.

Secondary

MeasureTime frame
Body weight. Timepoint: befor and after intervention. Method of measurement: kg.;Severity of diarrhea. Timepoint: befor and after intervention. Method of measurement: stool consistency score and frequency of diarrhea in 24 hours.;State of dehydration. Timepoint: befor and after intervention. Method of measurement: the state of dehydration, using the World Health Organization's dehydration scale.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactkumars Purrostami

Alborz University of Medical Sciences

kumarspurrostami@abzums.ac.ir+98 26 3433 6009

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026